The healthcare law created an approval pathway for biosimilars, or follow-on biologics, which are generic versions of protein-based products. The FDA said in the guidance documents that it expects biosimilars to be “highly similar” to the reference product, which is the original biological product that received approval.
“These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers,” said Dr. Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, in a news release.
According to one guidance, the 351(k) applications for biosimilars must include analytical studies showing the biological product is highly similar to the reference product, animal studies, and a clinical study or studies that show safety, purity and potency for the condition in which the reference product is licensed.
The FDA also said that it plans to use a “totality-of-the-evidence” approach to evaluating the data and information included in a biosimilar application.
The Generic Pharmaceutical Association said that competition from generic versions of biosimilars will help keep costs down for biologic medicines.
“As proven with chemical prescription drugs, competition from generics will be the most important factor in holding down the cost of biologic medicines,” the GPhA said in a written statement. “We look forward to continuing to work with the agency to ensure that a regulatory mechanism is developed that does not serve as a barrier to competition, but rather would ensure the robust competition needed to lower costs and spur future innovation.”
Last month, the FDA submitted recommendations to Congress for the proposed Biosimilar and Interchangeable Products User Fee program.